Trial · NCT02955589
Efficacy and Safety of Oral HBI-8000 in Patients With Relapsed or Refractory Adult T Cell Lymphoma (ATL)
NCT02955589, Phase 2, Completed, HUYABIO International, LLC.; results first posted 2024-09-19
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Efficacy and Safety of Oral HBI-8000 in Patients With Relapsed or Refractory Adult T Cell Lymphoma (ATL). Trials, record NCT02955589. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02955589
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety of Oral HBI-8000 in Patients With Relapsed or Refractory Adult T Cell Lymphoma (ATL)
- NCT number
- NCT02955589
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 23 participants, actual
- Lead sponsor
- HUYABIO International, LLC.
- Conditions
- Adult T-Cell Lymphoma (ATL)
- Interventions
- HBI-8000
- First posted
- 2016-11-04
- Last updated
- 2024-09-19
- Results first posted
- 2024-09-19
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Objective Response Rate | Tumor response was assessed until disease progression or unacceptable toxicity, up to 15 months. | Objective response rate (CR+CRu+PR) was determined based on the response of all compartments (lymph nodes, extranodal masses, spleen \& liver, skin, peripheral blood, and bone marrow) per Tsukasaki criteria and skin lesions were evaluated according to modified SWAT. CR: The disappearance of all disease whereby all criteria met; All compartments are normal. CRu: Lymph nodes ≥75% decrease and extranodal masses ≥75% decrease, but presence of residual lesion; spleen, liver, skin, peripheral blood and bone marrow are normal. PR: Lymph nodes and extradnodal masses - Reduction rate of the sum of 2 dimension products of ≥50% and ≤75%, no increase spleen /liver, skin lesion ≥50% decrease and peripheral blood ≥50% decrease. |
| Secondary | Objective Response Rate by Disease Subtype | Tumor response was assessed until disease progression or unacceptable toxicity, up to 15 months. | Objective response rate (CR+CRu+PR) by disease subtype (acute ATL, lymphoma ATL, unfavorable chronic ATL) was determined based on the response of all compartments (lymph nodes, extranodal masses, spleen \& liver, skin, peripheral blood, and bone marrow) per Tsukasaki criteria and skin lesions were evaluated according to modified SWAT. |
| Secondary | Median Duration of Progression-free Survival (PFS) | From the first day of HBI-8000 dose to the day of disease progression or death, which ever came first, through the end of the study (up to 15 months). | PFS was defined as the duration from the date of the first study drug dose to the disease progression or death, whichever occurs first. Evaluation of progression/progressive disease is performed according to the modified criteria of the International Consensus Meeting. Progression is defined as a 50% increase in the sum of 2-dimension products of nodal and/or extra nodal lesions, or 25% increase of mSWAT score in skin lesion, or 50% increase of absolute count of abnormal lymphocyte, or the appearance of new lesions. |
| Secondary | Median Duration of Response (DOR) | Through the end of the study (up to 12 months). | Median duration of response from first response CR, CRu, PR, date to progression, death or last available tumor assessment. |
| Other | Median Duration of Overall Survival (OS) | Until death, assessed every 3 months up to 12 months after last treatment through the end of the study (up to 30 months). | Median duration of overall survival is from start of the study to death. |
| Other | Safety and Tolerability, Evaluated as Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0 | From date of first subject's consent until 30 days after last treatment, assessed up to 25 months. | Safety and tolerability, evaluated as number of participants with treatment-related adverse events as assessed by CTCAE v4.0. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Objective Response Rate | Tumor response was assessed until disease progression or unacceptable toxicity, up to 15 months. | Per Protocol Set | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Objective Response Rate by Disease Subtype | Tumor response was assessed until disease progression or unacceptable toxicity, up to 15 months. | Per Protocol Set | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Median Duration of Progression-free Survival (PFS) | From the first day of HBI-8000 dose to the day of disease progression or death, which ever came first, through the end of the study (up to 15 months). | Per Protocol Set | Weeks | MEDIAN |
| SECONDARY | Median Duration of Response (DOR) | Through the end of the study (up to 12 months). | Per Protocol Set | Weeks | MEDIAN |
| OTHER_PRE_SPECIFIED | Median Duration of Overall Survival (OS) | Until death, assessed every 3 months up to 12 months after last treatment through the end of the study (up to 30 months). | Per Protocol Set | Weeks | MEDIAN |
| OTHER_PRE_SPECIFIED | Safety and Tolerability, Evaluated as Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0 | From date of first subject's consent until 30 days after last treatment, assessed up to 25 months. | Safety Analysis Set | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Objective Response Rate | HBI-8000 | 7 | Participants | ||
| Objective Response Rate by Disease Subtype | HBI-8000 Acute ATL | 6 | Participants | ||
| Objective Response Rate by Disease Subtype | HBI-8000 Lymphoma ATL | 1 | Participants | ||
| Objective Response Rate by Disease Subtype | HBI-8000 Unfavorable Chronic ATL | 0 | Participants | ||
| Median Duration of Progression-free Survival (PFS) | HBI-8000 | 7.6 | 95% Confidence Interval 3.4 to 32.1 | Weeks | |
| Median Duration of Response (DOR) | HBI-8000 | 40.0 | 95% Confidence Interval 11.4 to NA | Weeks | |
| Median Duration of Overall Survival (OS) | HBI-8000 | 34.4 | 95% Confidence Interval 10.1 to 78.3 | Weeks | |
| Safety and Tolerability, Evaluated as Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0 | HBI-8000 | 23 | Participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | HBI-8000 | 23 | |
| Overall Study | COMPLETED | HBI-8000 | 23 | |
| Overall Study | NOT COMPLETED | HBI-8000 | 0 |
Source ClinicalTrials.gov
Adverse events28
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | HBI-8000 | 8 | 23 | 19 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | HBI-8000 | 3 | 23 | 29 |
| other | Diarrhoea | Gastrointestinal disorders | HBI-8000 | 6 | 23 | 7 |
| other | Abdominal pain | Gastrointestinal disorders | HBI-8000 | 3 | 23 | 3 |
| other | Nausea | Gastrointestinal disorders | HBI-8000 | 3 | 23 | 4 |
| other | Malaise | General disorders | HBI-8000 | 7 | 23 | 10 |
| other | Pyrexia | General disorders | HBI-8000 | 3 | 23 | 5 |
| other | Fatigue | General disorders | HBI-8000 | 3 | 23 | 6 |
| other | Platelet count decreased | Investigations | HBI-8000 | 15 | 23 | 64 |
| other | Neutrophil count decreased | Investigations | HBI-8000 | 11 | 23 | 53 |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | HBI-8000 | 16 | 23 |
| Total, other adverse events | HBI-8000 | 23 | 23 |
| Total, serious adverse events | HBI-8000 | 7 | 23 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 35579212 | RESULT |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02955589
GET https://conductscience.org/api/trials/v1/NCT02955589/events?page=2